Therapeutic Innovation & Regulatory Science

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Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency
Therapeutic Innovation & Regulatory Science - Tập 56 - Trang 753-764 - 2022
Jenn W. Sellers, Camelia M. Mihaescu, Kassa Ayalew, Phillip D. Kronstein, Bei Yu, Yang-Min Ning, Miguel Rodriguez, LaKisha Williams, Ni A. Khin
The United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) have collaborated in good clinical practice (GCP) inspections since September 2009. The two agencies operate under different regulatory frameworks for GCP oversight. No systematic assessments of GCP inspection findings have been reported. We identified common inspections of clinical investigators, sponsors, an...... hiện toàn bộ
New Benchmarks Characterizing Growth in Protocol Design Complexity
Therapeutic Innovation & Regulatory Science - Tập 52 - Trang 22-28 - 2018
Kenneth A. Getz, Rafael A. Campo
The Tufts Center for the Study of Drug Development and Medidata Solutions Inc analyzed data from 9737 protocols and 130,601 investigative site contracts associated with these protocols to derive updated benchmarks characterizing protocol complexity. The results of the study indicate that protocol design complexity continues to grow rapidly. Nearly all phase I, II, and III complexity measures assoc...... hiện toàn bộ
FDA Engages Collaborators to Address Nonclinical Data Challenges
Therapeutic Innovation & Regulatory Science - Tập 47 - Trang 41-45 - 2013
Timothy J. Kropp, Lilliam A. Rosario, Susan DeHaven, William Houser, Lou Ann Kramer, Shree Nath, Troy Smyrnios, Jeremy L. Wally
FDA and PhUSE cohosted a Computational Science Symposium (CSS) in 2012 that brought stakeholders from the pharmaceutical industry and government to work collaboratively to solve common needs and challenges. A nonclinical informatics workgroup was formed, dedicated to improving nonclinical assessments and regulatory science by identifying, collecting, and prioritizing key needs and challenges in th...... hiện toàn bộ
Improving the Standards of Reporting of Clinical Trial Data
Therapeutic Innovation & Regulatory Science - Tập 54 - Trang 717-722 - 2020
Jitendra Ganju
Although checklists and guidelines for reporting and interpretation of clinical trial results are of immense value there is still room for a biased presentation in journal publications. Two important sources of bias that remain are as follows: (1) The absence of a principle guiding the display of point estimates in abstracts. For example, bias arises, even for a primary endpoint, when the reported...... hiện toàn bộ
Wearable Technologies for Children with Chronic Illnesses: An Exploratory Approach
Therapeutic Innovation & Regulatory Science - Tập 55 Số 4 - Trang 799-806 - 2021
Flora McErlane, Elin Haf Davies, Cécile Ollivier, Anna Mayhew, Obuchinezia Anyanwu, Victoria Harbottle, Aimée Donald
Nonclinical Immunotoxicity Testing in the Pharmaceutical World: The Past, Present, and Future
Therapeutic Innovation & Regulatory Science - Tập 54 - Trang 586-597 - 2020
Paul Baldrick
An examination for potential direct or indirect adverse effects on the immune system (immunotoxicity) is an established component of nonclinical testing to support safe use of new drugs. Testing recommendations occur in various regulatory guidance documents, especially ICH S8, and these will be presented. Key evaluation usually occurs in toxicology studies with further investigative work a conside...... hiện toàn bộ
Validation of Prognostic Marker Tests: Statistical Lessons Learned From Regulatory Experience
Therapeutic Innovation & Regulatory Science - Tập 50 - Trang 241-252 - 2016
Rong Tang, Gene Pennello
Despite concerted efforts to discover and validate prognostic biomarkers or signatures, few medical tests indicated for prognostic uses have been widely accepted by the clinical community. Even fewer, perhaps, are covered by public or private health plans. We were able to identify 6 prognostic marker tests that have been approved or cleared by the US Food and Drug Administration. The pivotal clini...... hiện toàn bộ
Advancing the Practice of CRCs Why Professional Development Matters
Therapeutic Innovation & Regulatory Science - Tập 52 - Trang 708-717 - 2018
Linda S. Behar-Horenstein, Alena Prikhidko, H. Robert Kolb
Clinical research coordinators (CRCs) assume critical responsibilities central to the success of the research team. The complexity of their role requires essential professional qualifications. One barrier to professionalization, however, has been the inconsistent, or absent, competency-based training. This study explored participants’ perceptions of training experiences designed to prepare them fo...... hiện toàn bộ
Insights from a Multi-company Workshop to Apply a Patient Participation Burden Algorithm to Protocol Data
Therapeutic Innovation & Regulatory Science - Tập 57 - Trang 262-270 - 2022
Zachary Smith, Emily Botto, Christopher Carney, Abhishek Bagga, Bazgha Qutab, Kenneth Getz
Utilizing a participation burden algorithm developed in a previous study, Tufts CSDD, in collaboration with ZS, led a workshop among 8 pharmaceutical companies to validate the methodology of benchmarking the participation burden of a set of retrospective protocols and comparing these data to a prospective protocol design. Eight participating companies collected data for 66 retrospective protocols...... hiện toàn bộ
Việc Sử Dụng Các Kiểm Soát Ngoài Trong Quyết Định Điều Hành Của FDA Dịch bởi AI
Therapeutic Innovation & Regulatory Science - - 2021
Mahta Jahanshahi, Keith Gregg, Gillian Davis, Adora Ndu, Veronica Miller, Jerry Vockley, Cécile Ollivier, Tanja Franolic, Sharon Sakai
Tóm tắtCác tiêu chuẩn quy định của Cục Quản lý Thực phẩm và Dược phẩm Hoa Kỳ (FDA) yêu cầu phải có bằng chứng rõ ràng về hiệu quả từ các thử nghiệm thích hợp và được kiểm soát tốt, thường sử dụng một so sánh hợp lệ với một kiểm soát đồng thời nội bộ. Tuy nhiên, khi việc sử dụng một kiểm soát nội bộ không khả thi hoặc không đạo đức, đặc biệt là trong các quần thể bệ...... hiện toàn bộ
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